BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON* 60 ENDOPATH**

    MDR report key: 1883727 · Received October 27, 2010

    Report

    Report Number
    3005075853-2010-06107
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT ONE LONG60 DEVICE WAS RECEIVED. THE DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH TWO FULLY FIRED RELOADS PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKE FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS, ROUX EN Y. THE DEVICE WAS FIRST FIRED TRANSVERSELY OVER THE STOMACH AND SECOND FIRING WAS VERTICAL OVER THE STOMACH IN THE PROCESS OF CREATING A POUCH. WAS FIRING WITH A 60MM BLUE RELOAD. THE SURGEON NOTICED ON EACH CARTRIDGE THE MIDLINE STAPLES WERE MALFORMED. (SECOND STROKE AREA) ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON* 60 ENDOPATH** STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TC8K

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)